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Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

NCT01428180 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2016-04-06

No results posted yet for this study

Summary

The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Conditions

  • Prematurity of Fetus
  • Patent Ductus Arteriosus

Interventions

DRUG

Indomethacin

3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)

PROCEDURE

Surgical Ligation

In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

DRUG

Ibuprofen

3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Manuel B Schmid, Dr. med. · University of Ulm

Eligibility

Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-10-31
Completion
2016-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428180 on ClinicalTrials.gov